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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K150894
Device Name VIA 21 Microcatheter
Applicant
Sequent Medical, Inc.
11a Columbia
Aliso Viejo,  CA  92677
Applicant Contact Bethany Barrett
Correspondent
Sequent Medical, Inc.
11a Columbia
Aliso Viejo,  CA  92677
Correspondent Contact Bethany Barrett
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received04/02/2015
Decision Date 08/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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